Clinical Research Coordinator

Research for new drugs is an ongoing process. It is expensive, energy-consuming, and time-consuming.

An investigational new drug (IND), a new health product, or a new treatment for an existing product must undergo strict research studies and tests before it is made available to the public. This can sometimes take up to fifteen years!

Clinical trial management (research) is a stringently regulated process in which human subjects (volunteers) participate in a research study.

• CenterWatch More than 5,200 clinical trials are listed here, actively recruiting human subjects. Search by therapeutic area and geographic region.

During these studies, human subjects are monitored by specific procedures that are outlined in the study's protocol (design). Data is collected and analyzed, based upon the protocol. Safety (how safe a study drug or a mechanical device is for the human subject) and efficacy (how well the drug or the device is in treatment) are monitored closely.

There are typically four phases during a drug's development, during which safety and efficacy are constantly monitored. The following are simplified definitions:

• Phase I --- a study drug is given to healthy human subjects; GOAL: to see if the study drug is safe
• Phase II --- a study drug is given to human subjects with the specific disease; GOAL: to see if the study drug is safe and if the study drug is effective against the specific disease
• Phase III--- two drugs (the study drug and another similar drug) are compared by giving the study drug to one group of human subjects with the specific disease and an already established effective drug to another group of human subjects with the specific disease; GOAL: to see if the study drug is as effective or more effective than the established drug
• Phase IV --- the study drug is made available to the public

ACRP delineates separate definitions of two, among many, personnel who are involved in the conduct of a study: Clinical Research Coordinator (CRC) and Clinical Clinical Research Associate (CRA).

A CRC is employed on the study staff at a clinical site (a medical facility, such as a doctor's office or a hospital) where the study is conducted. Typically referred to as CRCs, these are study coordinators, research nurses, or site managers. ACRP offers certification and continuing education programs to members and non-members.

• Association of Clinical Research Professionals

SoCRA defines a Clinical Research Associate (CRA) as someone who "functions as an administrator, coordinator, consultant, educator, or researcher" in clinical trial management. SoCRA offers certification and continuing education programs for members and non-members.

• Society of Clinical Research Associates

DIA is an organization in which health professionals exchange and share information on the discovery, development, evaluation, and utilization of health care medicines and technologies. The DIA provides opportunities for continuing education to professionals.

• Drug Information Association

The CRA Registry is an organization with whom auditors, monitors, data reviewers and study coordinators can register their resumes for potential employers such as CROs, Pharmaceutical sponsors, and Medical Device companies.

• The CRA Registry

There are several organizations that monitor the participation and the safety of human subjects in drug studies, as well as regulate the conduct of research studies, worldwide. The International Conference on Harmonisation is one organization in which regulatory authorities from Europe, Japan and the United States join with experts from the pharmaceutical industry to discuss scientific and technical aspects of product registration. In the United States, The Food and Drug Administration (FDA) regulates drug research and development process. Institutional Review Boards (IRBs) are regional, state, or local agencies that ensure the safety of human subjects.

• The International Conference of Harmonisation
• The Food and Drug Administration

The CRC functions under the supervision of a principal investigator (usually a physician) who is legally responsible for the conduct of the study, as outlined by certain regulations of The Food and Drug Administration (FDA). Guidelines to Good Clinical Practices (GCPs) are followed to protect the rights and welfare of human subjects and to ensure the quality, integrity and transparency of data in clinical trials.

• Guidelines to Good Clinical Practices

Some of the many responsibilities of a CRC include:

• site preparation (submitting appropriate documents to local IRBs, ordering supplies, arranging facilities for the conduct of the study, coordinating with local agencies, etc.)
• human subject screening and recruitment (identifying potential human subjects, obtaining medical histories, verifying that human subjects meet the requirements for a study protocol)
• human subject enrollment (explaining protocol procedures to human subjects, directing appropriate questions to principal investigator)
• maintaining and dispensing drug supplies (verifying that human subjects are taking the study drug as directed by the protocol, retrieving unused and used study drug and containers)
• completing and ensuring the quality of case report forms (recording data accurately, transcribing collected data to appropriate forms, storing data for a specified period of time)
• maintaining source documents (writing information for a specific patient in a medical chart)
• ensuring site quality (coordinating procedures and processes of a protocol in a timely, efficient manner).

Many CRCs perform additional duties:

• obtaining vital signs (measuring blood pressure, heart rate, respirations rate, temperature, height, and weight of a human subject)
• maintaining a medication log (recording medications that a human subject takes during participation on the study)
• obtaining labs (drawing blood, obtaining urine, and preparing sputum samples from human subjects in the study for protocol-specific tests)
• packaging lab samples (following regulated handling procedures and using specifically designed containers) for shipment to a central lab (a contracted laboratory facility) for analysis.

As you can see, a CRC is a very important and active participant on the study team.

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